The OptiBreech Care Trial: a small randomised trial to determine whether a large trial is possible for women with a breech-presenting baby at term

Not Applicable

• Conditions: Breech pregnancy; Pregnancy and Childbirth; Maternal care for breech presentation

• Registration Number: ISRCTN14521381
• Lead Sponsor: King's College London

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37967120/ Pilot (added 16/11/2023) 2023 Preprint results in https://doi.org/10.3310/nihropenres.13500.1 (added 04/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-18
• Last Update Posted: 15 January 2024
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

Current participant inclusion criteria as of 07/09/2023:
1. Live, singleton pregnancy with a breech-presenting fetus confirmed by ultrasound scan
2. Over 16 years of age
3. Referred for specialist care for breech presentation antenatally from 32 weeks
4. Breech presentation from 37 weeks discovered in labour
5. Requesting or preferring a vaginal birth
6. Giving informed consent to participate in contributing data
7. Consent to randomisation to be offered new treatments that are being tested (only for pilot trial)

Previous participant inclusion criteria:
1. Live, singleton pregnancy with a breech-presenting fetus confirmed by ultrasound scan
2. Over 16 years of age
3. Referred for specialist care for breech presentation antenatally from 32 weeks
4. Breech presentation from 37 weeks discovered in labour
5. Requesting or preferring a vaginal birth
6. Giving informed consent to participate in contributing data
7. Consent to randomisation to be offered new treatments that are being tested

Exclusion Criteria

1. Absolute reason for caesarean section already exists (e.g. placenta praevia major)
2. Requesting a caesarean section prior to recruitment
3. Multiple pregnancy
4. Life-threatening congenital anomaly
5. Not consenting to contribute data to the study
6. Has already had an ECV attempt prior to recruitment
7. Rhesus isoimmunisation
8. Current or recent (less than 1 week) vaginal bleeding
9. Evidence of antenatal fetal compromise, including abnormal electronic fetal monitoring
10. Rupture of the membranes
11. Hyperextended neck on ultrasound
12. Estimated fetal weight less than 2000 g or less than 10th centile at recruitment
13. Estimated fetal weight greater than 3800g or over 95th centile at recruitment
14. Standing/footling presentation at the time of recruitment, defined as hips extended and breech not engaged
15. Any indication at the time of recruitment for induction to be recommended prior to 41 weeks of pregnancy, e.g. gestational diabetes, obstetric cholestasis, advanced maternal age
16. Breech diagnosed for the first time in labour
17. Two or more previous caesarean sections

Study & Design

• Study Type: Interventional
• Study Design: Not specified